EP3600406A1 - Vaccins bivalents à base de vlp contre le virus ebola et leurs procédés de fabrication et d'utilisation - Google Patents

Vaccins bivalents à base de vlp contre le virus ebola et leurs procédés de fabrication et d'utilisation

Info

Publication number
EP3600406A1
EP3600406A1 EP18778205.7A EP18778205A EP3600406A1 EP 3600406 A1 EP3600406 A1 EP 3600406A1 EP 18778205 A EP18778205 A EP 18778205A EP 3600406 A1 EP3600406 A1 EP 3600406A1
Authority
EP
European Patent Office
Prior art keywords
ebola
composition
vlp
cell line
gag
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP18778205.7A
Other languages
German (de)
English (en)
Other versions
EP3600406A4 (fr
Inventor
Karnail SINGH
Paul Spearman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cincinnati Childrens Hospital Medical Center
Original Assignee
Cincinnati Childrens Hospital Medical Center
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cincinnati Childrens Hospital Medical Center filed Critical Cincinnati Childrens Hospital Medical Center
Publication of EP3600406A1 publication Critical patent/EP3600406A1/fr
Publication of EP3600406A4 publication Critical patent/EP3600406A4/fr
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/08RNA viruses
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • A61K2039/5258Virus-like particles
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/10023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/11011Alpharetrovirus, e.g. avian leucosis virus
    • C12N2740/11023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/12011Betaretrovirus, e.g. mouse mammary tumour virus
    • C12N2740/12023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/13011Gammaretrovirus, e.g. murine leukeamia virus
    • C12N2740/13023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/14011Deltaretrovirus, e.g. bovine leukeamia virus
    • C12N2740/14023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/15011Lentivirus, not HIV, e.g. FIV, SIV
    • C12N2740/15023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/16011Human Immunodeficiency Virus, HIV
    • C12N2740/16022New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2740/00Reverse transcribing RNA viruses
    • C12N2740/00011Details
    • C12N2740/10011Retroviridae
    • C12N2740/16011Human Immunodeficiency Virus, HIV
    • C12N2740/16023Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/14011Filoviridae
    • C12N2760/14111Ebolavirus, e.g. Zaire ebolavirus
    • C12N2760/14122New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/14011Filoviridae
    • C12N2760/14111Ebolavirus, e.g. Zaire ebolavirus
    • C12N2760/14123Virus like particles [VLP]
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/14011Filoviridae
    • C12N2760/14111Ebolavirus, e.g. Zaire ebolavirus
    • C12N2760/14134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

Definitions

  • FIG. 1 Inducible expression of EBOV GP, SUDV GP and HIV-1 Gag in ESGPGag 293F cells. Cells were cultured as such or induced with Dox for 24 h and cell ly sates probed by western blotting for EBOV GP, SUDV GP, HIV-1 Gag and actin using specific antibodies.
  • the disclosed VLP platform may be used for large-scale production of a nanoparticle bivalent Ebola vaccine.
  • the production system is based on a stable and inducible ESGPGag 293F cell line that, upon induction with doxycycline (Dox), secretes VLPs with HIV-1 Gag core abundantly studded with Ebola glycoproteins (GPs) from Zaire (EBOV) and Sudan (SUDV) Ebolaviruses.
  • the Gag core provides a very stable framework of ⁇ 1 lOnm on which Ebola GPs are incorporated in their native conformation.
  • Initial immunogenicity results in rabbits are highly promising, with high binding titers and substantial neutralization elicited against all the four pathogenic Ebolavirus species.
  • Sequence identity may be measured using sequence analysis software on the default setting (e.g., Sequence Analysis Software Package of the Genetics Computer Group, University of Wisconsin Biotechnology Center, 1710 University Avenue, Madison, Wis. 53705). Such software may match similar sequences by assigning degrees of homology to various substitutions, deletions, and other modifications.
  • compositions herein may incorporate known injectable, physiologically acceptable sterile solutions.
  • aqueous isotonic solutions such as e.g. saline or corresponding plasma protein solutions are readily available.
  • the immunogenic and vaccine compositions of the present invention can include diluents, isotonic agents, stabilizers, or adjuvants.
  • Diluents can include water, saline, dextrose, ethanol, glycerol, and the like.
  • Isotonic agents can include sodium chloride, dextrose, mannitol, sorbitol, and lactose, among others.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

L'invention concerne des compositions de vaccin bivalent à base de pseudo-particules virales (VLP). Les compositions peuvent comprendre un noyau protéique de l'antigène « Gag » sphérique et au moins deux glycoprotéines du virus Ebola. Lesdites au moins deux glycoprotéines du virus Ebola peuvent être situées au niveau de la surface extérieure du noyau protéique Gag sphérique, de sorte que le vaccin à base de VLP présente au moins deux antigènes de glycoprotéine du virus Ebola. Dans un aspect, lesdites au moins deux glycoprotéines du virus Ebola sont une glycoprotéine du virus Ebola Zaïre (EBOV) et une glycoprotéine du virus Ebola Soudan (SUDV).
EP18778205.7A 2017-03-28 2018-03-28 Vaccins bivalents à base de vlp contre le virus ebola et leurs procédés de fabrication et d'utilisation Pending EP3600406A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762477480P 2017-03-28 2017-03-28
PCT/US2018/024747 WO2018183435A1 (fr) 2017-03-28 2018-03-28 Vaccins bivalents à base de vlp contre le virus ebola et leurs procédés de fabrication et d'utilisation

Publications (2)

Publication Number Publication Date
EP3600406A1 true EP3600406A1 (fr) 2020-02-05
EP3600406A4 EP3600406A4 (fr) 2021-01-13

Family

ID=63677003

Family Applications (2)

Application Number Title Priority Date Filing Date
EP18778205.7A Pending EP3600406A4 (fr) 2017-03-28 2018-03-28 Vaccins bivalents à base de vlp contre le virus ebola et leurs procédés de fabrication et d'utilisation
EP18776312.3A Pending EP3600367A4 (fr) 2017-03-28 2018-03-28 Vaccins monovalents à base de vlp contre ebola et leurs procédés de préparation et d'utilisation

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP18776312.3A Pending EP3600367A4 (fr) 2017-03-28 2018-03-28 Vaccins monovalents à base de vlp contre ebola et leurs procédés de préparation et d'utilisation

Country Status (4)

Country Link
US (4) US11129886B2 (fr)
EP (2) EP3600406A4 (fr)
CA (2) CA3056927A1 (fr)
WO (2) WO2018183443A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11129886B2 (en) 2017-03-28 2021-09-28 Children's Hospital Medical Center VLP-based bivalent Ebola vaccines and methods of making and using same

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9045727B2 (en) 2002-05-17 2015-06-02 Emory University Virus-like particles, methods of preparation, and immunogenic compositions
JP2009519715A (ja) * 2005-12-16 2009-05-21 ザ ユーエービー リサーチ ファウンデーション ウイルスベクターを使用する制御された遺伝子発現に関する組成物および方法
US20100143406A1 (en) 2006-06-30 2010-06-10 Gale Smith Methods of enhancing protein incorporation into virus like particles
WO2012122858A1 (fr) * 2011-03-17 2012-09-20 中国科学院上海巴斯德研究所 Procédé de production d'une particule apparentée à un virus par utilisation de cellule de drosophila et ses applications
CA3194125A1 (fr) * 2012-04-12 2013-10-17 The Trustees Of The University Of Pennsylvania Antigenes consensus de filovirus, constructions d'acides nucleiques et vaccins a base de ceux-ci, et leurs methodes d'utilisation
WO2015066715A1 (fr) 2013-11-04 2015-05-07 Viracell Advanced Products, Llc Pseudo-particules virales et procédés qui leur sont associés
US9969986B2 (en) 2014-08-08 2018-05-15 Vlp Therapeutics, Llc Virus like particle comprising modified envelope protein E3
WO2016168187A1 (fr) 2015-04-13 2016-10-20 The Regents Of The University Of Michigan Particules de type virus
WO2017015457A1 (fr) * 2015-07-21 2017-01-26 Modernatx, Inc. Vaccin contre le virus ebola
US11129886B2 (en) 2017-03-28 2021-09-28 Children's Hospital Medical Center VLP-based bivalent Ebola vaccines and methods of making and using same

Also Published As

Publication number Publication date
EP3600406A4 (fr) 2021-01-13
WO2018183435A1 (fr) 2018-10-04
EP3600367A4 (fr) 2021-01-13
WO2018183443A1 (fr) 2018-10-04
US20200085936A1 (en) 2020-03-19
US12280100B2 (en) 2025-04-22
EP3600367A1 (fr) 2020-02-05
US11890337B2 (en) 2024-02-06
US11129886B2 (en) 2021-09-28
US20200085937A1 (en) 2020-03-19
CA3056927A1 (fr) 2018-10-04
CA3057138A1 (fr) 2018-10-04
US20240131141A1 (en) 2024-04-25
US20210386849A1 (en) 2021-12-16
US12427190B2 (en) 2025-09-30

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